Individual study plan

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Bedside assessment of Microvascular Dysfunction Method evaluation in clinical studies

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Bedside assessment of Microvascular Dysfunction
Method evaluation in clinical studies

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Disposition

  • Introduction and Background: Introduction to the topic, research objectives
  • Research plan and Methodology: Study designs, methods and analysis
  • Timeline and Milestones: Project timeline with key milestones
  • Education: Courses, journal clubs, conferences
  • Degree outcomes
  • Resources and Support: Overview of resources and support


Introduction and Background

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Relevance


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Relevance


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Introduction and Background

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Relevance

Key Areas: Cardiovascular disease, diabetes, heart failure, sepsis

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Relevance

Key Areas: Cardiovascular disease, diabetes, heart failure, sepsis

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Clinical Implications

Early Detection and Prevention: Monitoring microvascular function helps identify patients at high risk, enabling early intervention and preventive measures.

Disease Progression and Treatment Monitoring: Microvascular assessment provides a window into disease activity, aiding in the evaluation of treatment effectiveness.

Goal-Directed Therapy: Insights into microvascular health support goal-directed therapies, optimizing treatment plans tailored to individual needs.

Introduction and Background

Problem

Current methods

Capillary refill time
Subjectivity, variability, sens/spec, non-quantifiable*
Coronary angiography
Invasive, cumbersome, resource intensive, organ specific
Stress Cardiac MRT
Cumbersome, resource intensive, organ specific
Biomarkers
Analysis time, interpretation, resource intensive


Introduction and Background

Problem

Future methods - what is needed?

Quantitative
Precision and comparison
Non-invasive
Risk and discomfort
Low variability and High sensitivity
Consistency and precision
Rapid and ease of use
Clinical convenience
Organ-agnostic
Systemic dysfunction
Cost-effective
Iterative usage and goal-directed


Research Plan and Methodology

  • The CapriS Study, Capillary Dysfunction in Sepsis
    • Patients with severe sepsis or septic shock
      • Rapid microvascular decompensation
  • The MIND Study, Microangiopathy in Diabetes
    • Patients with type 1 diabetes, with and without clinical microangiopathy
      • Chronic microvascular deterioration
  • SCAPIS2Spectrum, Microcirculation Substudy
    • Patients with high risk of cardiac microangiopathy
      • Microangiopathy in different populations

Research Plan and Methodology
Picture of LSCI

Research Plan and Methodology
Picture of curves

Research Plan and Methodology

CapriS, Capillary Dysfunction in Sepsis

Population: 60 patients, >18 yrs with confirmed/suspected infection at ICU/IMCU <12hrs and SBP <90mmHg despite 10 mL/kg cristalloid.
Intevention: Laser speckle contrast imaging, with iontophoresis. Biomarkers. Echocardiography at set intervals.

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30 healthy controls.
Primary outcome: peak capillary blood cell velocity (pCVB, mm/s)
Secondary outcomes: Severity of condition, macrocirculatory parameters, biomarkers.

======= Comparison: 30 healthy controls.

Outcomes: Primary outcome: peak capillary blood cell velocity (pCVB, mm/s). Secondary outcomes: Severity of condition, macrocirculatory parameters, biomarkers.

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Research Plan and Methodology

MIND, Microangiopathy in Diabetes

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  • Patient
  • Intervention
  • Comparison
  • Outcome
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Population: Patients with DM1 at diabetes outpatient clinic at Danderyd Hospital.
Pilot: 20 healthy controls.
Phase 1: 50 patients with severe DM1 complications and 50 healthy controls.
Phase 2: 100 patients with no microangiopathy, 100 patients with mild microangiopathy, 50 with moderate microangiopathy, as classified by microangiopathy score [1].
Intervention: LSCI, blood tests and charts.
Controls: Healthy controls in each cohort.
Outcomes: Thermal regulation, flow regulation

[1]: 10.1177/1479164120928303

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Research Plan and Methodology

SCAPIS2Spectrum, Microcirculation Substudy

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  • Patient
  • Intervention
  • Comparison
  • Outcome
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Population: Substudy to SCAPIS2. 900 in total to be included in 5 arms; O-CAD, ANOCA, HFpEF, HFrEF and diabetes, including corresponding controls from SCAPIS2 cohort.

Intervention: LSCI, biomarkers, and adenosine stress cardiac MRI.

Comparison: Healthy controls

Outcome: Primary outcomes: Flowmotion analysis, post-occlusion hyperemeia, thermal provocations. Secondary outcomes: Biomarkers


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Timeline and Milestones

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displayMode: compact
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gantt
    tickInterval 1year
    dateFormat YYYY-MM
    section Studies
        Microangiopathy IN Diabetes(MIND)           :             2024-01, 2027-06
        Capillary dysfunction in Sepsis(CapriS)     :             2024-01, 2028-06
        SCAPIS2Spectrum - Microcirculation substudy :             2024-03, 2029-01
    section Conferences
        European Society on Microcirculation        :milestone    2025-05, 2025-06
        ISICEM                                      :milestone    2026-03, 2026-04
        European Society on Microcirculation        :milestone    2027-04, 2027-05
    section Journal clubs
        IMA-Journal Clubs                           :             2024-08, 2029-05
    section Milestones
        Start date                                  :milestone,           2024-08, 2024-08
        Half-Time Control                           :milestone,           2026-08, 2026-08
        Dissertation Defense                        :milestone, crit,     2029-05, 2029-05


Timeline and Milestones

gantt
    dateFormat YYYY-MM
    section Mandatory courses
        Introduction to Doctoral Education at KI    :             2024-10, 2024-12
        Basic Laboratory Safety                     :             2024-12, 2025-01
        Medical Research Ethics                     :             2025-01, 2025-02
        Introductory course in clinical studies     :             2025-02, 2025-03
        Basic Course in Medical Statistics          :             2025-03, 2025-04
        Present your Research!                      :             2025-10, 2025-11
        Quality Assurance of Clinical Research      :             2025-10, 2025-11
    section Project specific courses
        Statistical Methods with R                  :             2024-09, 2024-12
        Programing in Python                        :             2024-08, 2024-11
        Endothelial Cell Function[...]              :             2026-02, 2026-03
        Intermediate Medical Statistics             :             2026-03, 2026-04
        Cellular Signalling                         :             2026-04, 2026-05
    section Milestones
        Start date                                  :milestone,           2024-08, 2024-08
        Half-Time Control                           :milestone,           2026-08, 2026-08
        Dissertation Defense                        :milestone, crit,     2029-05, 2029-05


Education

  • All courses listed here, 20 hp wow

Education

Journal clubs and conferences

  • wow so many journal clubs

Degree outcomes

  • So many outcomes!

Challanges and Risk Management

  • Large Scale Studies
    • Participant Scheduling
      • Automatic scheduling system
    • Data Collection
      • Partially automatic data collection and integrity system
  • Data Analysis Phase
    • Well-defined analytic aims
    • Specific courses

Resources and Support

  • Supervisor: Sara Tehrani, MD, PhD, MICU specialist
  • Co-Supervisor: Maria Cronhjort, MD, PhD, anesthesiologist and ICU specialist

Discussion and Feedback


Jacob Widaeus - Karolinska Institute, Department of Clinical Sciences, Danderyd Hospital